Alcami will be attending BIO International Convention, to be held June 3 - 6, 2019 in Philadelphia, PA.

Be sure to stop by Booth #3401 and connect with the Alcami team.

Alcami continues to make science, technology, engineering, and mathematics (STEM) education and training initiatives a priority in 2019, this time partnering with Homestead High School in Mequon, Wisconsin, to support the school’s growing robotics club. The company has agreed to sponsor Homestead’s 2019 competitions and demonstrations, which will help its club purchase new computers and 3D printers. On average, teams invest approximately $4,000 to build a robot from the ground up and participate in competitions.

Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.

“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Senior Manager of Stability Services, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”

Students 2 Science (S2S) is a New Jersey-based nonprofit committed to inspiring and educating elementary, middle, and high school students to pursue careers in science, technology, engineering, and mathematics (STEM). Through strategic partnerships between businesses, institutions of higher education, district leadership, and workforce-readiness agencies, S2S provides students with real life laboratory problem-solving experiences led by scientific professionals using modern technology and instrumentation. S2S’s V-Laboratory educational program enlists corporate partners such as Alcami to serve as in-class mentors and help introduce students to the broad spectrum of STEM careers available to them.

Name: Bhadresh Nayee
Alcami Site: Edison, NJ

How long have you been with Alcami?
I have been with Alcami since 2007.

What is your role? 
I’m working as a microbiology analyst at our Edison, New Jersey site. My day-to-day activities involve antibiotic testing, container closure integrity testing, and isolating/creating cultures of bacteria to study the impact of these microorganisms in order to obtain information on types and levels of microbial contamination.

What is the most rewarding part of your job?
The most rewarding part of my job is our clients' satisfaction from my work.

Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a Certificate of Compliance by the European Medicines Agency (EMA) Tuesday, April 23, 2019, following the facility’s recent successful Good Manufacturing Practice (GMP) inspection. Certification confirms the site is compliant with GMP laboratory storage and testing practices, and enables the laboratory to process more commercial products for the European Union (EU). The outcome reflects the company’s unwavering commitments to quality, reliability, responsible operations, and strict adherence to regulatory compliance.

Alcami recently contributed to an article in the Greater Wilmington Business Journal titled, "Overcoming the Opioid Overdose Crisis."

Our community has come together, like many others, to combat the opioid crisis. Several local agencies have rallied to create impactful community resources. A 2016 survey by Castlight, which listed Wilmington, NC as the #1 city for opioid abuse in the United States, was a wake-up call to the level of severity this community has been affected by opioid-related fatalities and hardships. At Alcami, we work with our clients to develop abuse deterrence medicines to help combat this nationwide epidemic that hits home, even here in Wilmington.

Alcami employees, their families, and friends celebrated Earth Day 2019 by cleaning up green spaces, beaches, waterways, sidewalks, and streets in the company’s local communities. More than 30 volunteers participated in this year’s preservation efforts, including cleanups at Wrightsville Beach, Carolina Beach, and Isle of Palms Beach, near Wilmington, North Carolina and Charleston, South Carolina; business park and nature trail litter removal in Germantown, Wisconsin; and growing new plant life in Durham, North Carolina. Combined, these efforts will protect native wildlife and enhance public gathering places for all to enjoy.

Solid state chemistry plays a major role in successfully developing a compound into a drug product. The physical and mechanical properties are important in selecting the most appropriate stable form with sufficient solubility. The occurrence of crystallization from a crude reaction mixture is the first step towards obtaining a pure drug substance.

For process chemists crystallization is an essential tool for isolation and purification of the compound in a robust and reproducible way. In addition, the crystallization conditions impact the crystal form or polymorph, particle habit, and its characteristics like stability and bio-availability. Optimized pharmaceutically-acceptable crystallization conditions are established by varying cooling profile and slurry conditions, by adding anti-solvent, or by applying seeding to obtain the preferred form, if needed.

Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. To keep up with this impressive growth rate, many contract development and manufacturing organizations (CDMOs) are making strategic investments in equipment and expertise to support analytical development and structural characterization of biopharmaceuticals in more economical and efficient ways.^[1] Unlike small molecule active pharmaceutical ingredients (APIs) that exist as a single chemical entity, biologics nearly always exist as a mixture of molecules. Different molecules can arise from numerous sources including N-terminal variants, post-translation modifications (PTMs), glycoforms, and degradation products. Due to the potentially high amount of heterogeneity in the biologic, it is critical to demonstrate control over the drug substance (DS) manufacturing process from fermentation to purification and protein re-folding. Characterization of the various molecules is the first step in demonstrating process control. High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.